Table 5. Mean Change From Baseline To Eot In Ecg Parameters In The Pooled 8-Week Or 52-Week Studies.
| POOLED 8-WK STUDIES | ||||||||
|---|---|---|---|---|---|---|---|---|
| VILAZODONE n = 436 | PLACEBO n = 433 | 52-WK STUDY N = 599 | ||||||
| PARAMETER | BASELINE, MEAN (SD) | LSM (SE), CHANGE AT WK 8/EOT | BASELINE, MEAN (SD) | LSM (SE), CHANGE AT WK 8/EOT | P VALUEa | BASELINE, MEAN (SD) | CHANGE AT WK 52/EOT, MEAN (SD) | |
| Heart rate, bpm | 67.3 (11.1) | 1.9 (0.5) | 66.9 (10.0) | 3.0 (0.4) | 0.088 | 66.7 (10.5) | 3.6 (10.2) | |
| PR interval, ms | 155.2 (20.5) | −0.9 (0.6) | 157.0 (20.5) | −0.2 (0.6) | 0.428 | 158.4 (22.0) | −1.7 (13.3) | |
| QRS interval, ms | 88.6 (9.7) | −1.3 (0.4) | 87.7 (9.6) | −0.1 (0.4) | 0.022 | 87.5 (10.2) | −0.9 (6.9) | |
| QTcB, ms | 405.6 (24.6) | −0.6 (0.9) | 403.1 (24.4) | 1.7 (0.9) | 0.072 | 401.6 (24.6) | 2.1 (22.0) | |
| QTcF, ms | 398.9 (21.7) | −2.4 (0.8) | 396.7 (21.7) | −1.3 (0.7) | 0.309 | 395.6 (21.4) | −1.3 (18.2) | |
| QT interval, ms | 386.2 (30.2) | −5.7 (1.1) | 384.3 (28.0) | −6.8 (1.1) | 0.481 | 383.9 (28.0) | −8.0 (24.0) | |
ANCOVA, analysis of covariance; bpm, beats per minute; EOT, end of treatment; LSM, least-squares mean; ms, millisecond; QTcB, QT interval corrected (Bazett); QTcF, QT interval corrected (Fridericia); SD, standard deviation; SE, standard error; wk, week.
a
P value for treatment group difference based on difference in LSM change from baseline from an ANCOVA model with terms for treatment group and study with baseline value included as a covariate.